Clinical trials: Performance and Safety
- Condition Performance and Safety
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Bradycardia, Sinus Node Dysfunction
Safety and Performance Study of the INGEVITY Lead
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
- Trial name
- NCT01688843
- Testing
- INGEVITY lead
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 1,060 people
- Sponsor
- Boston Scientific Corporation
Hip Arthropathy
Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF.
- Trial name
- 2022-09 (NCT06096155)
- Where
- France
- Volunteers
- 46 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Nasolabial Fold, Safety
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds. There is an 18 months follow up period.
- Trial name
- NCT03300466
- Testing
- GP0045, Comparator
- Where
- Sweden
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Safety and Effectiveness of the Siello S Lead
Safety and Performance Study of the Siello S Pacing Lead
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
- Trial name
- SIELLO (NCT01791127)
- Testing
- market-released BIOTRONIK pacemaker system including one or two Siello S leads.
- Where
- 53 sites in United States
- Volunteers
- 1,758 people
- Sponsor
- Biotronik, Inc.
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Acne Scars
Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring.
- Trial name
- NCT03821324
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Dry Eye
A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
The primary objectives of this investigation are to show that the performance of CBL-101 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days…
- Trial name
- NCT02975102
- Testing
- CBL-101 Eye Drops, Vismed® Multi Eye Drops
- Where
- 2 sites in Belgium, France
- Volunteers
- 87 people
- Sponsor
- Laboratoire Chauvin
Cataract
Cataract Surgery: Femto LDV Z8 Versus Conventional
The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract…
- Trial name
- COMFORT (NCT02351271)
- Testing
- Femto LDV Z8, Manual capsulorhexis&lens fragmentation
- Volunteers
- 130 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Hearing Loss
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- Sponsor
- Cochlear
Peripheral Arterial Disease
Safety and Performance Study of the Shockwave Lithoplasty System
To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of…
- Trial name
- DISRUPT-PAD (NCT02071108)
- Testing
- Shockwave Lithoplasty System
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 35 people
- Sponsor
- Shockwave Medical, Inc.
Localized T1-T2 Prostate Cancer
SpaceOAR System RWS in China
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting…
- Trial name
- NCT05407714
- Testing
- SpaceOAR Treatment
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Heart Defects, Congenital
Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries.
- Trial name
- XEL-CR-06 (NCT02377700)
- Testing
- Xeltis Vascular Patch, Model COR-VP-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis
Peripheral Neuropathy
BlueWind Medical Reprieve System for the Treatment of PNP
The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.
- Trial name
- PNP (NCT02062398)
- Testing
- The Reprieve System
- Where
- 4 sites in Belgium, Poland
- Volunteers
- 13 people
- Sponsor
- BlueWind Medical
Primary Open Angle Glaucoma
Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant
To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg
- Trial name
- NCT01563237
- Testing
- MIDI Arrow
- Where
- France
- Volunteers
- 69 people
- Sponsor
- InnFocus Inc.
Mitral Regurgitation
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
- Trial name
- ASCEND (NCT04382612)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 10 sites in Austria, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Edwards Lifesciences
Diabetic Foot Ulcers
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).
- Trial name
- CHEXU 01 (NCT02091778)
- Testing
- Fast gelling dressing
- Where
- 2 sites in United Kingdom
- Volunteers
- 21 people
- Sponsor
- Molnlycke Health Care AB
Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients.
- Trial name
- NCT03085238
- Testing
- M-Trap
- Where
- 8 sites in Spain
- Volunteers
- 23 people
- Sponsor
- MTrap, Inc.
Ileostomy - Stoma
Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
- Trial name
- NCT01957384
- Testing
- Coloplast Test product 1, Coloplast Test product 2, Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Coloplast A/S
Leakage, Skin Condition
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.
- Trial name
- NCT01517178
- Testing
- New ostomy base plate (SS), Standard Care base plate
- Where
- 11 sites in Denmark, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Coloplast A/S
Heart Defects, Congenital
Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle.
- Trial name
- EC-TCPC (NCT02377674)
- Testing
- Vascular Graft, Model COR-VG-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis